About this trial
This study investigates the effects of foods enriched with alternative protein sources, including edible insects, microalgae, hemp, and legumes, on appetite regulation, satiety, food preferences, and metabolic health in healthy adults and individuals with overweight. The study is part of the CIPROMED project, which aims to support sustainable and circular food systems in the Mediterranean area.
The study consists of two phases. In the acute phase, participants will consume different protein-enriched bread products in a controlled setting following a randomized crossover design. Each participant will be exposed to multiple test conditions, allowing within-subject comparisons of postprandial responses. Outcomes assessed during this phase include satiety, hunger, food preference, craving, and short-term energy intake, measured using validated scales and dietary assessment tools.
In the chronic phase, participants will follow structured dietary interventions over a longer period within a Mediterranean dietary framework. Participants will be assigned to different dietary patterns including alternative protein-based foods and control products. This phase aims to evaluate the effects of repeated consumption of alternative protein sources on metabolic parameters, gastrointestinal tolerance, nutritional status, and behavioral responses.
The study aims to assess the acceptability and physiological effects of alternative protein sources and to compare their impact with that of traditional protein sources commonly used in Mediterranean diets.
Eligibility criteria
Qualifiers
Providing signed informed consent,
Being between 18 and 65 years of age,
Having a body mass index (BMI) within the normal range, defined as between 18.5 and 24.9 kg/m² or Having a body mass index (BMI) between 25.0 and 34.9 kg/m², inclusive, corresponding to the overweight category or, at most, class I obesity.
Disqualifiers
Positive and documented history of allergy to legumes, insects, microalgae, shellfish, mollusks, crustaceans, snails, insect venom, house dust mites, or any component (ingredient or additive) present in the food prototypes tested, or a confirmed or suspected diagnosis of Celiac Disease.
History of severe allergic reactions to any type of allergen.
Pregnancy or Breastfeeding
Trial design
Treatments tested in this trial
- Mediterranean Diet with Control Products (chronic phase)
- Mediterranean Diet with Insect Protein Bread (chronic phase)
- Mediterranean Diet with Seaweed-Based Burger (chronic phase)
Treatment groups
Sponsors and collaborators
University of Bologna
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
University of Turin, Italy
Collaborator
Azienda Usl di Bologna
Collaborator